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Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00949039
First received: July 7, 2009
Last updated: March 11, 2015
Last verified: March 2015

July 7, 2009
March 11, 2015
February 2009
March 2014   (final data collection date for primary outcome measure)
Survival rate [ Time Frame: From randomization to death ] [ Designated as safety issue: Yes ]
survival
Complete list of historical versions of study NCT00949039 on ClinicalTrials.gov Archive Site
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Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
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Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gynaecologic or Digestive Pelvic Cancer
  • Drug: Isolated pelvis perfusion
    injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg
  • Radiation: radiotherapy
    chemotherapy and/or radiotherapy and/or surgery
  • Procedure: Surgery
  • Experimental: Chemotherapy
    Isolated pelvis perfusion
    Intervention: Drug: Isolated pelvis perfusion
  • Active Comparator: Control
    Standard treatment
    Interventions:
    • Radiation: radiotherapy
    • Procedure: Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
  • Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
  • Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
  • Patients aged over 18 and under 76 ans
  • Performance OMS Index ≤ 2
  • Normal biologic parameters
  • Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

  • Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
  • Cardiac or vascular pathology
  • Pulmonary disease
  • Uncontrolled Sepsis disease
  • Pregnancy
Both
18 Years to 76 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00949039
PIP2, CSET 1443
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Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
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Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP